• Directed cell line development of in HEK293 and CHO, master cell bank development, USP and DSP development, formulation development, engineering batches (DS, DP and packaged), GMP batches through final packed product and stability programs for DS and DP. • Reviewed and approved CMC documentation (e.g. reports, master batch records) from CMOs and internally• Managed business and operational relationships with third parties: external organizations (CDMOs, CROs and CPOs), vendors and contractors. • Facilitated technology transfer between Research Discovery/Development project team and Contract Organizations• Authored IND CMC regulatory sections for multiple programs • Selected and managed Quality Assurance consulting for Maverick Therapeutics. • Managed implementation of Quality Management System including drafting and implementing SOPs• Collaborated with project management to develop and track an integrated CMC and Clinical IND plan for four oncology programs • Member of Site Senior Leadership Team

• Directed manufacturing activities for drug product (biologic/small molecule) and devices, to meet early to late phase deliverables, quality, and cost objectives for Novartis Technical Research and Development (TRD) and external Partners• Planned and administered operational resources, procedures and budgets to ensure both global and site strategies were implemented and operational objectives were achievedo Developed financial and resource budgeting for manufacturing (CAPEX and direct/indirect labor) • Tasked with managing all aspects of GMP manufacturing areas including maintenance, calibration, HSE oversight, life cycle management and operational efficiencyo Developed, monitored and reported KPIs o Implemented and drove continuous improvement intitiatives (e.g. 5S and Kaizan)• Developed optimal schedules and personnel requirements for assigned areas and programs; building a technically competent and flexible manufacturing organizationo Prioritized based on product delivery/criticality, equipment efficiency, resources and materials supply• Managed business and operational relationships with third parties, external organizations (CMOs, CPOs), vendors and contractors as extension of Manufacturing• Tasked with overall manufacturing responsibility and accountability for regulatory and cGMP compliance o Represented Manufacturing during Health Authority, Global Corporate and Internal Quality Assurance audits• Facilitated technology transfer between project teams / process development and ensured high quality transfer of processes and methods to Novartis TechOps o Coordinated cross-functional support within Materials Management, Quality Control, Quality Assurance, Process Development, Pharmaceutical Development, Facilities, Finance and other relevant functions • Supported CMC activities including regulatory filings (IND, NDA)and PAI preparedness

• Responsible for all CMO/CPO activities (biologics and small molecule) including supply chain o Ensured on time and in-full (OTIF) delivery, manufacturing and release of API, bulk drug substance, drug product and clinical trial materials to support clinical, launch and commercial supply demando Led cross functional Due Diligence teams in assessing CMOs and other vendors. Supported QA audits and qualification of CMOs o Collaborated with stakeholders & legal support to negotiate supply/technical agreements and SOWs, RFPs, RFQs for both current and new vendors. o Presented metric updates, risks and opportunities in regular updates to management and project stakeholderso Managed timely meetings (steering/business including QBRs) with CMOs/vendors and other stakeholders • Managed production issues including investigations, material review boards and corrective/preventative actions (CAPAs) and audit observations• Worked with project management and process development technical leads, quality and regulatory, to develop and track an integrated CMC registration and launch plan• Supported cross-functional late stage activities including technology transfers, process validation and CMC activities including regulatory filings and PAI preparations• Responsible for document activities related to clinical and commercial manufacturing (e.g. master and batch production record generation and review)

Primary commercial liaison between company and CMOs in commercial startupand manufacturing activities.Responsible for commercial activities including management of CommercialSupply Agreements, preparation of production forecasts, capacity expansionplans, onsite inventory –management (ERP), and evaluation of COGS.Responsible for execution of capacity expansion plans as well as qualityimprovement initiatives.Developed and managed formal project plans, with identified critical paths,timing, cost, resource requirements/allocations, and risk mitigations to ensurethat projects and commercial activities met quality, schedule, and cost goals.Managed day-to-day production issues as they develop including investigations,MRBs and CAPAs.Provided leadership for a diverse array of cross-functional teams addressingquality, commercial and organizational issues.Worked cooperatively with a wide variety of stakeholders including vendors,manufacturing suppliers (CMOs), internal departments, and partners.Supported execution of validation activity (IOPQ) and regulatory filings (initialNDA and annual APQR).Coordinated with Product Transfer teams on issues such as technical concerns,capacity expansion, alternative manufacturing processes, and yieldimprovement initiatives.Managed multiple direct reports and provided leadership and mentorship tocross-functional team.

Established Europharma Inc. subsidiary in America North (Canada and UnitedStates)Responsible for all commercial operations of Europharma Inc. (financials,quality, regulatory, products)Supply chain and inventory management of vaccines, drugs and APIsEstablished and implemented SOP system and protocols for importation,distribution, QA and QC.Regulatory affairs contact – Health Canada and CCVB (responsible for newproduct submissions, inspections and audits)Scheduled reporting of key objectives to leadership including executive andmanufacturers.Manage product traceability for recall, stop sale and product stewardship andqualityTraining of junior staff to ensure operational, regulatory, OHSA andenvironmental compliance, and TDG.Investigating and evaluating new APIs, vaccines and diagnostics.

Responsible for manufacturing operations at both Microtek-Bayotek and CMOs(in North America and EU)Executed and facilitated the technological transfer of new products to GMPCMOs in North America and Europe (product development and pre-licensingbatches)Identified and qualified CMOs for manufacturing suitability, quality and COGS.Negotiated production and supply agreements with CMOs and vendorsPrepared and initiated forecasts (timelines), schedules and managed inventory(raw materials, bulk intermediates, final product)Performed audits of vendors and CMOsPrepared budgets, COGS and present and forward looking operational planswith respect to scale-up, cost reduction and new product manufacturing.Ensured GxP and regulatory compliance of manufactured productsCollaborated with cross-functional groups (research, quality, regulatorydevelopment and production) in product transfer and manufactureManagement of supply chain (APIs, finished product) to/from CMOsCommunicated reports of key objectives, monthly status reports, metrics andmilestones to senior management.Developed and implemented process improvements (cost reduction,deliverables)Investigated and resolved technical manufacturing and quality challenges,manufacturing deviations, participated in change control and CAPA.Batch record preparation, SOP writing, review and GAP analysisProvided technical writing (CMC) for regulatory submissionsDevelopment, validation and implementation of in-process controls.Key involvement in regulatory inspections and auditsTraining of personnel in technical operations

Prepare batch records, Perform in-coming inspection,Responsible for SOP document controlResponsible for analytical and microbial testing